David S Metzger1, Deborah Donnell, David D Celentano, J Brooks Jackson, Yiming Shao, Apinun Aramrattana, Liu Wei, Liping Fu, Jun Ma, Gregory M Lucas, Marek Chawarski, Yuhua Ruan, Paul Richardson, Katherine Shin, Ray Y Chen, Jeremy Sugarman, Bonnie J Dye, Scott M Rose, Geetha Beauchamp, David N Burns. 1. *Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and Treatment Research Institute, Philadelphia, PA; †Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; §Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD and Department of Pathology, University of Minnesota, Minneapolis, MN; ‖State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Beijing, China; ¶Department of Family Medicine, Faculty of Medicine, Chiang Mai University; #Guangxi Centers for Disease Control and Prevention, Guangxi Center for HIV/AIDS Prevention and Control, Nanning, China; **Xinjiang Autonomous Region Center for Disease Control and Prevention, Xinjiang, China; ††Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD; ‡‡Department of Psychiatry, Yale School of Medicine, New Haven, CT; §§Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD; ‖‖Division of AIDS, Pharmaceutical Affairs Branch, National Institute of Allergy and Infectious Diseases; ¶¶Division of Intramural Research, National Institute of Allergy and Infectious Diseases; ##Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD; ***FHI 360; †††Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division; and ‡‡‡Division of AIDS, Prevention Sciences Branch, National Institute of Allergy and Infectious Diseases.
Abstract
BACKGROUND: Injection opioid use plays a significant role in the transmission of HIV infection in many communities and several regions of the world. Access to evidence-based treatments for opioid use disorders is extremely limited. METHODS: HIV Prevention Trials Network 058 (HPTN 058) was a randomized controlled trial designed to compare the impact of 2 medication-assisted treatment (MAT) strategies on HIV incidence or death among opioid-dependent people who inject drugs (PWID). HIV-negative opioid-dependent PWID were recruited from 4 communities in Thailand and China with historically high prevalence of HIV among PWID. A total of 1251 participants were randomly assigned to either (1) a 1-year intervention consisting of 2 opportunities for a 15-day detoxification with buprenorphine/naloxone (BUP/NX) combined with up to 21 sessions of behavioral drug and risk counseling [short-term medication-assisted treatment (ST-MAT)] or (2) thrice-weekly dosing for 48 weeks with BUP/NX and up to 21 counseling sessions [long-term medication-assisted treatment (LT-MAT)] followed by dose tapering. All participants were followed for 52 weeks after treatment completion to assess durability of impact. RESULTS: Although the study was stopped early due to lower than expected occurrence of the primary end points, sufficient data were available to assess the impact of the interventions on drug use and injection-related risk behavior. At week 26, 22% of ST-MAT participants had negative urinalyses for opioids compared with 57% in the LT-MAT (P < 0.001). Differences disappeared in the year after treatment: at week 78, 35% in ST-MAT and 32% in the LT-MAT had negative urinalyses. Injection-related risk behaviors were significantly reduced in both groups after randomization. CONCLUSIONS: Participants receiving BUP/NX 3 times weekly were more likely to reduce opioid injection while on active treatment. Both treatment strategies were considered safe and associated with reductions in injection-related risk behavior. These data support the use of thrice-weekly BUP/NX as a way to reduce exposure to HIV risk. Continued access to BUP/NX may be required to sustain reductions in opioid use.
RCT Entities:
BACKGROUND: Injection opioid use plays a significant role in the transmission of HIV infection in many communities and several regions of the world. Access to evidence-based treatments for opioid use disorders is extremely limited. METHODS: HIV Prevention Trials Network 058 (HPTN 058) was a randomized controlled trial designed to compare the impact of 2 medication-assisted treatment (MAT) strategies on HIV incidence or death among opioid-dependent people who inject drugs (PWID). HIV-negative opioid-dependent PWID were recruited from 4 communities in Thailand and China with historically high prevalence of HIV among PWID. A total of 1251 participants were randomly assigned to either (1) a 1-year intervention consisting of 2 opportunities for a 15-day detoxification with buprenorphine/naloxone (BUP/NX) combined with up to 21 sessions of behavioral drug and risk counseling [short-term medication-assisted treatment (ST-MAT)] or (2) thrice-weekly dosing for 48 weeks with BUP/NX and up to 21 counseling sessions [long-term medication-assisted treatment (LT-MAT)] followed by dose tapering. All participants were followed for 52 weeks after treatment completion to assess durability of impact. RESULTS: Although the study was stopped early due to lower than expected occurrence of the primary end points, sufficient data were available to assess the impact of the interventions on drug use and injection-related risk behavior. At week 26, 22% of ST-MATparticipants had negative urinalyses for opioids compared with 57% in the LT-MAT (P < 0.001). Differences disappeared in the year after treatment: at week 78, 35% in ST-MAT and 32% in the LT-MAT had negative urinalyses. Injection-related risk behaviors were significantly reduced in both groups after randomization. CONCLUSIONS:Participants receiving BUP/NX 3 times weekly were more likely to reduce opioid injection while on active treatment. Both treatment strategies were considered safe and associated with reductions in injection-related risk behavior. These data support the use of thrice-weekly BUP/NX as a way to reduce exposure to HIV risk. Continued access to BUP/NX may be required to sustain reductions in opioid use.
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